The present invention relates generally to materials for making medical grade products. More specifically, the present invention relates to medical grade port tubing.
It is known in the medical industry to house products such as fluids that are administered to a patient in plastic containers. Heretofore, some flexible containers have been constructed from polyvinyl chloride.
It is also known to use medical port tubing (ports) to provide access either to a container or from a container. Such medical port tubing has uses in such therapies as renal and blood. It is also known to construct the medical port tubing from polyvinyl chloride.
In order to make polyvinyl chloride sufficiently flexible, so that it can be used to create flexible containers and port tubing, plasticizers have been added thereto. The toxicity of plasticizers has increasingly become a matter of concern both in processing the material into a product, e.g., container or port tubing, and in the end use of the material. In the medical industry, typically, DEHP and/or epoxidized oils are utilized as plasticizers for polyvinyl chloride. Recently, however, DEHP has become a suspect compound in that there is continued testing to determine if DEHP is a health hazard. Additionally, polyvinyl chloride is perceived to be an environmentally unfriendly material.
Examples of therapies wherein flexible containers including port tubing are used include intravenous therapy, continuous ambulatory dialysis (CAPD), and blood therapy. In CAPD, the container includes a dialysis fluid that can be infused into the peritoneym of the patient through the port tubing that is fused to the container.
Typically, for medical uses, there are a variety of characteristics that a medical port tube should have. Among the characteristics the port tube should exhibit is the ability to be bonded to a material from which the container may be constructed. For example, it is known in manufacturing containers with port tubing to radio frequency RF seal such port tubings to a container. It is also desirable that the port tubing can be heat sealable so as to be compatible with equipment used in certain of the medical industries.
Furthermore, such port tubing should be sufficiently flexible as well as translucent. Additionally, the port tubing, if it is coextruded, must not easily delaminate.
Typically, polyvinyl chloride plasticized with DEHP has been used to achieve these needs. However, as previously noted, the use of DEHP has been under some scrutiny and criticism.